Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Washington University School of Medicine
Study ID
NCT03141034
Phase
PHASE2
Status
Completed

Conditions

  • Gastric Adenocarcinoma
  • Gastro-esophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    -Irinotecan is commercially available and will be billed to insurance.
  • Ramucirumab — DRUG
    -Ramucirumab will be provided free of charge by Eli Lilly and Company.
  • Blood for angiome profiling — GENETIC
    -Before treatment on cycle 1 day 1, cycle 5 day 1, cycle 9 day 1, and end of treatment
  • Blood for cfDNA — GENETIC
    -Before treatment on cycle 1 day 1, cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, cycle 9 day 1, and end of treatment

Study Details

The investigators hypothesize that this combination regimen of irinotecan plus ramucirumab administered as second line treatment will be tolerated and lead to improved outcomes similar to paclitaxel plus ramucirumab in patients with advanced gastric and gastro-esophageal junction (GEJ) cancers. This study proposes a phase II clinical trial with irinotecan plus ramucirumab for treatment of patients with metastatic gastric and GEJ adenocarcinoma who have progressed after first line chemotherapy. To the knowledge of the investigators, this regimen has not been previously administered to this patient population, so safety and tolerability will be monitored and reported.

Key Dates

Start date
Nov 1, 2017
Status verified
Jun 2024
Primary completion
Apr 14, 2023
Completion
Apr 14, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan plus ramucirumab
    -Patients will receive ramucirumab intravenously on an outpatient basis at a dose of 8 mg/kg over the course of 60 minutes on Day 1 of each 14-day cycle. They will then receive irinotecan intravenously at a dose of 180 mg/m2 over the course of 90 minutes on Day 1 of each 14-day cycle.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 30 months from completion of treatment (up to 36 months) ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
H. Lee Moffitt Cancer Center and Research Institute, Inc.TampaFlorida33612-
Washington University School of MedicineSt LouisMissouri63110-
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Miami, FL

By research site
University of Miami - Sylvester Comprehensive Cancer Center· Miami, FLH. Lee Moffitt Cancer Center and Research Institute, Inc.· Tampa, FLWashington University School of Medicine· St Louis, MOUT Southwestern Medical Center· Dallas, TX

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